Chimeric antigen receptor (CAR) T-cell therapies were in the spotlight at the BIO International Convention in Philadelphia last week, and BioPharma-Reporter had the chance to speak with Matthew Hewitt, head of clinical development for Lonza's personalized medicine group about the company’s plans to meet industry demand.
While the emerging market increases the companies’ needs on capacity, Lonza has been working on a space-saving approach, with closed capsules, hanging from ‘trees’.
Earlier this year, the contract development and manufacturing organisation (CDMO) established a clinical collaboration with Sheba Medical Center, the largest hospital in the Middle East and rated as one of the top ten hospitals in the world.
The center had an ongoing clinical trial utilizing cell therapies, treating patients “quite successfully, with very good clinical data,” according to Hewitt and it was looking for a way to increase the ability to treat more patients.
The scientists at Sheba had a deficiency in the number of ‘hands’ available. Hewitt explains that the Cocoon could assist on that, as, by closing and automating the process, fewer ‘hands’ and considerably less space are required.
“The ultimate goal is to serve larger patient populations. Because right now, the initial approvals for Kymriah and Yescarta are for patient populations of a few thousands per year,” says Hewitt.
“As we continue to bring cell therapies to market, inevitably, we will have to treat larger patient populations. And we're going to need to do that in a more efficient manner, if we have any hope of controlling the price,” he added.
According to Lonza’s executive, the focus lately has been put on the closed and automated portion of the manufacturing but fewer companies have been focusing on the scalability of the system.
“Instead of building millions upon millions of square feet of manufacturing space, we will utilize less expensive cleanroom space and then as a result require fewer people operating it, since it is a closed automated system,” he suggested.
The Cocoon contains a single-use cassette, with an input and an output side, which internalises all of the media, reagents and consumables used in the process.
Six to 10 Cocoons can be attached on a ‘Cocoon tree’, which has a footprint of one-square-meter, and that, according to Lonza, answers the needs for scalability, as in just a square meter it is possible to run up to ten processes. Cocoon trees are being built one next to another, as seen in the first image.
This manufacturing platform also simplifies the knowledge required by scientists for the process; Hewitt explained, “The people who we envision running these processes at a commercial scale are not necessarily going to be experts in cell therapy.”
“The complicated engineering is contained within the cassette, so that all you have to do is load the cassette into the Cocoon. And it only fits in one orientation,” he added.
Lonza has developed cassettes for lentiviral vector-based transduction systems and another for gamma-retroviral vector-based transduction systems, as well as for other autologous cell therapy processes.
The first patients are expected to be treated with the use of the Cocoon at Sheba Medical Center, by the end of the year.